Data / Medical devices / Belgium / Xeos Medical
Xeos Medical: FDA-registered device maker in Sint-Denijs-Westrem Oost-Vlaanderen, Belgium, 1 510(k) clearance
Xeos Medical is registered with the FDA (registration 3027847687) in Sint-Denijs-Westrem Oost-Vlaanderen, Belgium. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027847687
- Address
- Kortrijksesteenweg 1084 bus 301, Sint-Denijs-Westrem Oost-Vlaanderen, Belgium, 9051
- Owner or operator
- XEOS Medical (10088583)
- Roles
- Specification developer
- First device listed
- August 21, 2023
- Registered through
- 2026
- Brand names listed
- AURA 10 PET CT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cabinet, Emission Computed Tomography System | QXL | 2 | Specification developer | accessdata.fda.gov |
| Cabinet, X-Ray System | MWP | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2023 | K231420 | Aura 10 PET/CT | QXL | Substantially Equivalent | Xeos Medical | accessdata.fda.gov |
Compare with other makers
Updated August 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.